Respiratory syncytial virus (RSV) antibody detection kit (colloidal gold method) instructions

[Product Name] Respiratory Syncytial Virus (RSV) antibody detection kit (colloidal gold method)
[Packing specifications] 24 servings / box 48 servings / box [Intended use] For detecting respiratory syncytial virus antibodies (IgM / IgG) in test serum
[Test principle] Use the solid phase nitrocellulose membrane of respiratory syncytial virus antigen and apply the principle of diafiltration indirect method to detect the antibody of respiratory syncytial virus in serum.
[Main components]
1. 24 or 48 reaction plates
2. Reagent â…  1 bottle of 0.02mol / L PH 7.4 PBS
3. Reagent Ⅱ 1 bottle of colloidal gold marker [storage conditions and expiration date] The product should be stored at 2 ℃ ~ 8 ℃ conditions, can not be frozen; the expiration date is 24 months.
[Sample requirements]
1. Serum samples cannot be hemolyzed, and should be stored in fresh serum or stored at 2 ℃ ～ 8 ℃ for no more than one week.
2. Hyperlipidemia serum cannot be used.
【Testing method】
1. Drop two drops of reagent â…  into the central hole of the reaction plate and wait for complete infiltration;
2. Drip 100µl of serum into the well of the reaction plate, to be completely infiltrated;
3. Add three drops of reagent â…¡ to the well of the reaction plate until it is completely infiltrated;
4. Infiltrate three drops of reagent â…  into the well of the reaction plate and wait for complete infiltration.
[Interpretation of results]
Positive: Red round spots appear on the C end and red round spots appear on the T end of the reaction plate well, which is positive for antibodies to respiratory syncytial virus;
Negative: There are red round spots on the C-end and no red round spots on the T-end of the reaction plate well, which is negative for respiratory syncytial virus antibody.
Failure: No red round spots appear on the C-end of the reaction plate well, or no red round spots appear on the C-end and T-end.
[Limitations of inspection methods]
1. This reagent test is only used to detect respiratory syncytial virus antibodies instead of directly detecting respiratory syncytial virus antigens, so a positive result cannot confirm the diagnosis of respiratory syncytial virus infection. The diagnosis of the patient's condition should be combined with a comprehensive analysis of the patient's clinical signs and symptoms and test results.
2. It is possible that serum samples with low antibody content cannot be detected. Some patients with respiratory syncytial virus infection do not produce antibodies or produce a small amount of antibodies. At this time, a negative result may be displayed.
3. When the test result is suspicious, the PCR method is used to confirm the diagnosis.
【Product Performance Index】
1. In-batch precision: both the positive coincidence rate and the negative coincidence rate should be ≥95%, and the color depth of the reaction spots should be close.
2. Precision between batches: Both the positive and negative coincidence rates should be ≥95%.

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